AQST-109 maintained lower overall systemic exposure than reference products in recent clinical evaluations, according to data presented at a major scientific meeting.
Comparing AQST-109 Exposure Levels
Researchers evaluated the pharmacodynamic effects of the sublingual epinephrine film AQST-109, also known as dibutepinephrine or Anaphylm, at low systemic exposures. The lowest tertile was compared against reference products administered across 3 studies, including EpiPen, Auvi-Q, and manual intramuscular epinephrine, using Kruskal-Wallis or Mann-Whitney U tests, according to Hcplive.
In this low-exposure group, the geometric mean maximum concentration was 117.51 pg/mL with a 95% confidence interval of 107.2 to 128.1. That figure stayed below all tested reference products.
The median time to maximum concentration reached 20 minutes with a range of 5 to 120 minutes. This timeline proved comparable to autoinjectors and faster than manual intramuscular epinephrine.
AQST-109 Increases Blood Pressure and Heart Rate Faster than Comparators
The median maximum effect for systolic blood pressure, diastolic blood pressure, and mean arterial pressure proved greater with AQST-109 compared with all 3 reference products, Hcplive reported. The median time to maximum effect for all 3 blood pressure measures also ran faster against each comparator.
Peak heart rate in the lowest tertile registered greater with the investigational film than with manual intramuscular epinephrine. It also overlapped with both autoinjectors.
The heart rate time to maximum effect ran faster than intramuscular epinephrine, equaled EpiPen, and stayed close to Auvi-Q.
We’re treating people who need to have cardiovascular support in their anaphylactic reaction. Athletes, for example, get high levels of epinephrine and high levels of heart rate and blood pressure during normal exercise for them. So these are all within physiologic range. They’re not dangerous.
Golden, author affiliation and disclosures
Reviewing The Regulatory Timeline
AQST-109 is an investigational sublingual epinephrine prodrug film under FDA review for type I allergic reactions, including anaphylaxis. Aquestive Therapeutics announced an FDA acceptance of the Anaphylm new drug application resubmission with a Prescription Drug User Fee Act goal date set for March 16, 2027.
The findings were presented at the American College of Allergy, Asthma & Immunology 2026 Annual Scientific Meeting held from November 12 to 16, 2026, in Phoenix, Arizona. Golden, A. Anagnostou, K. Sokol, D. Mack, K. Rance, and M. Greenhawt.
AQST-109 Produces Faster Blood Pressure Responses Despite Lower Cmax
Why Cmax May Not Predict Epinephrine Response
Based on Hcplive reports, the investigational sublingual epinephrine prodrug film known as dibutepinephrine or Anaphylm (AQST-109) is evaluated by the FDA for type I allergic reactions like anaphylaxis, targeting a PDUFA goal date of March 16, 2027.
Among healthy adults in the lowest Cmax tertile, the treatment produced significantly greater and faster systolic blood pressure, diastolic blood pressure, and mean arterial pressure responses versus EpiPen, Auvi-Q, and intramuscular epinephrine.
Does a lower Cmax mean a weaker epinephrine response? Not with this sublingual film, according to the analysis.
As Golden said, achieving an effective threshold is all that is required for epinephrine, meaning an elevated Cmax does not inherently signal superior efficacy.
How high does it have to go to work, though? It doesn’t have to go to the Cmax. The higher the Cmax doesn’t mean it’s going to work any better.
Golden
